title: [Severe adverse events from treatment with genetically engineered biological agents in patients with rheumatic diseases].
abstract: OBJECTIVE
  To assess the risk of severe adverse events (AEs) within 6 months after treatment with biological agents in patients with rheumatic diseases (RD).
  
  
  METHODS
  The 6-month open-label trial included 107 patients with rheumatoid arthritis, antineutrophil cytoplasmic antibody-associated vasculitides, systemic lupus erythematosus, and other RDs who received genetically engineered biological agents (GEBAs), primarily rituximab (n = 66) and infliximab (n = 31).
  
  
  RESULTS
  The majority of patients were noted to have improvements, including complete and partial remission in 62 (57.9%) and 42 (39.3%), respectively. There were mild or moderate AEs in 22 (20.6%) of the 107 patients, severe AEs in 6 (5.6%): grade IV neutropenia in 2 patients (after the use of rituximab), severe infusion reactions in 2 (after the administration of infliximab and rituximab), and systemic infections in 2 (fatal nocardial sepsis after rituximab treatment and unspecified sepsis after infliximab treatment).
  
  
  CONCLUSIONS
  The rate of serious AEs, mainly infusion AEs and infections during treatment with infliximab, rituximab, and other GEBAs proved to be relatively low in patients with different RDs. At the same time, the use of biological agents could lower RD activity in the presence of severe visceral injuries refractory to conventional immunosuppressive therapy.
authors.forename: S V
authors.initials: SV
authors.lastname: Moiseev
authors.forename: P I
authors.initials: PI
authors.lastname: Novikov
authors.forename: E N
authors.initials: EN
authors.lastname: Semenkova
authors.forename: L A
authors.initials: LA
authors.lastname: Strizhakov
authors.forename: S V
authors.initials: SV
authors.lastname: Gulyaev
authors.forename: T N
authors.initials: TN
authors.lastname: Yanushkevich
authors.forename: N V
authors.initials: NV
authors.lastname: Nikiforova
authors.forename: A D
authors.initials: AD
authors.lastname: Meshkov
authors.forename: V V
authors.initials: VV
authors.lastname: Panasyuk
authors.forename: Yu D
authors.initials: YD
authors.lastname: Sokorin
authors.forename: M V
authors.initials: MV
authors.lastname: Taranova
authors.forename: S A
authors.initials: SA
authors.lastname: Parfenova
authors.forename: L V
authors.initials: LV
authors.lastname: Dubrovskaya
authors.forename: E S
authors.initials: ES
authors.lastname: Zhabina
authors.forename: E I
authors.initials: EI
authors.lastname: Kuznetsova
authors.forename: I A
authors.initials: IA
authors.lastname: Lopatina
authors.forename: N M
authors.initials: NM
authors.lastname: Bulanov
authors.forename: N A
authors.initials: NA
authors.lastname: Mukhin
mesh_terms: D000328:Adult; D056648:Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / Q000188:drug therapy / Q000503:physiopathology; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000503:physiopathology; D005260:Female; D005818:Genetic Engineering; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects* / Q000627:therapeutic use; D000069285:Infliximab; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy / Q000503:physiopathology; D008297:Male; D012074:Remission Induction / Q000379:methods; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000503:physiopathology; D000069283:Rituximab; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D007155:Immunologic Factors; D000069283:Rituximab; D000069285:Infliximab